Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Tempus AI
With
Medtronic
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
At least one of the following three options for aortic stenosis and/or the single option for mitral regurgitation are determined from echocardiogram findings:
1. AVA or DI (Patients with either Aortic valve area (AVA) or Dimensionless Index (DI) measured in their echo as well as at least one hemodynamic measure above the minimum threshold)
a. Either: i. Aortic Valve Area ≤ 1.0 cm2 ii. Dimensionless Index ≤ 0.25 b. AND ANY of i. Aortic Mean Gradient ≥ 15 mmHg ii. Aortic Peak Gradient ≥ 30 mmHg iii. Aortic Jet Velocity ≥ 2.75 m/s
2. AVA + OTHER (Patients with AVA and at least 1 other echo measurement in their echo above the threshold)
1. 1.0 cm2 \< Aortic Valve Area ≤ 1.2 cm2
2. AND ANY of:
i. Aortic Mean Gradient ≥ 40 mmHg ii. Aortic Peak Gradient ≥ 64 mmHg iii. Aortic Jet Velocity ≥ 4.0 m/s
3. POSSIBLE (Possible Aortic Stenosis but requires human review) a. Aortic Valve Area is NULL OR \>1.2 cm2 b. AND ANY of: i. Aortic Mean Gradient ≥ 40 mmHg ii. Aortic Peak Gradient ≥ 64 mmHg iii. Aortic Jet Velocity ≥ 4.0 m/s OR a. EITHER i. Aortic Valve Area ≤ 1.0 cm2 ii. Dimensionless Index ≤ 0.25 b. AND ALL are: i. Aortic Mean Gradient \< 15 mmHg ii. Aortic Peak Gradient \< 30 mmHg iii. Aortic Peak Velocity \< 2.75 m/s
ALERT Study Clinical Investigation Plan Version 2.1 page 12 of 54
Any patient flagged for "POSSIBLE" does not result in automatically alerting the provider, instead a notification is sent to the Tempus research team for manual review in conjunction with the site Principal Investigator (PI) and if requested by Tempus or site PI, a Steering Committee member. If clinical confirmation is received for severe aortic stenosis from the site PI, an alert is sent to the provider. 1. Mitral Regurgitation
a. Mention of severe mitral regurgitation or moderate- severe mitral regurgitation
Any patient mentioned with only moderate MR or a lesser severity will be excluded.
You may not be if
1. Age \< 18 years
2. Patient had evidence of a prior transcatheter or surgical repair or replacement of the target valve
3. The echocardiogram was ordered by a cardiologist on the MHT or a cardiac surgeon
4. Patient already has a scheduled clinic visit with a member of the MHT or a recent (since the start of the study at that site ) clinic visit with the MHT, or a scheduled transcatheter or surgical VI in the future.
